Trial Outcomes & Findings for A COVID-19 Study to Evaluate Safety and PK of COVID-HIG Administered Through IM, SC, or IV Routes to SARS-CoV-2 Uninfected Adults (NCT NCT05142306)
NCT ID: NCT05142306
Last Updated: 2025-06-08
Results Overview
Number of participants with AEs and severity of AEs up to 72 hours post-dosing.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
23 participants
Primary outcome timeframe
72 hours
Results posted on
2025-06-08
Participant Flow
Participant milestones
| Measure |
COVID-HIG Intramuscular (IM)
Eligible subjects will be randomized to receive an 8.5mL dose of COVID-HIG by IM injections.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
COVID-HIG Subcutaneous (SC)
Eligible subjects will be randomized to receive an 8.5mL dose of COVID-HIG by SC injections.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
COVID-HIG Intravenous (IV)
Eligible subjects will be randomized to receive an 8.5mL dose of COVID-HIG by IV infusion.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
8
|
8
|
|
Overall Study
Safety Population
|
7
|
8
|
7
|
|
Overall Study
COMPLETED
|
7
|
8
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
COVID-HIG Intramuscular (IM)
Eligible subjects will be randomized to receive an 8.5mL dose of COVID-HIG by IM injections.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
COVID-HIG Subcutaneous (SC)
Eligible subjects will be randomized to receive an 8.5mL dose of COVID-HIG by SC injections.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
COVID-HIG Intravenous (IV)
Eligible subjects will be randomized to receive an 8.5mL dose of COVID-HIG by IV infusion.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
Baseline Characteristics
A COVID-19 Study to Evaluate Safety and PK of COVID-HIG Administered Through IM, SC, or IV Routes to SARS-CoV-2 Uninfected Adults
Baseline characteristics by cohort
| Measure |
COVID-HIG Intramuscular (IM)
n=7 Participants
Eligible subjects will be randomized to receive an 8.5mL dose of COVID-HIG by IM injections.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
COVID-HIG Subcutaneous (SC)
n=8 Participants
Eligible subjects will be randomized to receive an 8.5mL dose of COVID-HIG by SC injections.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
COVID-HIG Intravenous (IV)
n=7 Participants
Eligible subjects will be randomized to receive an 8.5mL dose of COVID-HIG by IV infusion.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45.9 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
36.3 years
STANDARD_DEVIATION 13.0 • n=7 Participants
|
32.4 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
38.1 years
STANDARD_DEVIATION 11.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Height
|
172.57 centimeters
STANDARD_DEVIATION 3.88 • n=5 Participants
|
163.31 centimeters
STANDARD_DEVIATION 7.94 • n=7 Participants
|
170.14 centimeters
STANDARD_DEVIATION 6.28 • n=5 Participants
|
168.43 centimeters
STANDARD_DEVIATION 7.30 • n=4 Participants
|
|
Baseline weight
|
86.51 kilograms
STANDARD_DEVIATION 12.95 • n=5 Participants
|
67.29 kilograms
STANDARD_DEVIATION 13.78 • n=7 Participants
|
73.69 kilograms
STANDARD_DEVIATION 7.62 • n=5 Participants
|
75.44 kilograms
STANDARD_DEVIATION 13.96 • n=4 Participants
|
|
Baseline body mass index
|
28.94 kilograms per meter squared (kg/m^2)
STANDARD_DEVIATION 3.48 • n=5 Participants
|
25.09 kilograms per meter squared (kg/m^2)
STANDARD_DEVIATION 4.12 • n=7 Participants
|
25.56 kilograms per meter squared (kg/m^2)
STANDARD_DEVIATION 3.49 • n=5 Participants
|
26.46 kilograms per meter squared (kg/m^2)
STANDARD_DEVIATION 3.96 • n=4 Participants
|
|
Baseline SARS-CoV-2 Antibody Status
Seronegative
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Baseline SARS-CoV-2 Antibody Status
Seropositive
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Enrollment per Study Site
US6001 (Miami, FL)
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Enrollment per Study Site
US6002 (Springfield, MO)
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 72 hoursPopulation: Safety population includes all participants who received any amount of study treatment.
Number of participants with AEs and severity of AEs up to 72 hours post-dosing.
Outcome measures
| Measure |
COVID-HIG Intramuscular (IM)
n=7 Participants
Eligible participants will be randomized to receive an 8.5mL dose of COVID-HIG by IM injections.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
COVID-HIG Subcutaneous (SC)
n=8 Participants
Eligible participants will be randomized to receive an 8.5mL dose of COVID-HIG by SC injections.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
COVID-HIG Intravenous (IV)
n=7 Participants
Eligible participants will be randomized to receive an 8.5mL dose of COVID-HIG by IV infusion.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
|---|---|---|---|
|
Participants With Adverse Events (AEs) up to 72 Hours Post-dosing
|
2 Participants
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: Safety population includes all participants who received any amount of study treatment.
Number of participants and severity of AEs that led to discontinuation or temporary suspension of study treatment.
Outcome measures
| Measure |
COVID-HIG Intramuscular (IM)
n=7 Participants
Eligible participants will be randomized to receive an 8.5mL dose of COVID-HIG by IM injections.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
COVID-HIG Subcutaneous (SC)
n=8 Participants
Eligible participants will be randomized to receive an 8.5mL dose of COVID-HIG by SC injections.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
COVID-HIG Intravenous (IV)
n=7 Participants
Eligible participants will be randomized to receive an 8.5mL dose of COVID-HIG by IV infusion.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
|---|---|---|---|
|
Participants With Adverse Events That Led to Discontinuation or Temporary Suspension of Study Treatment
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 0 to Day 57Population: Safety population includes all participants who received any amount of study treatment.
Number of participants with adverse events (AEs) and serious adverse events (SAEs) up to 56 days post-administration of a single dose of COVID-HIG.
Outcome measures
| Measure |
COVID-HIG Intramuscular (IM)
n=7 Participants
Eligible participants will be randomized to receive an 8.5mL dose of COVID-HIG by IM injections.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
COVID-HIG Subcutaneous (SC)
n=8 Participants
Eligible participants will be randomized to receive an 8.5mL dose of COVID-HIG by SC injections.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
COVID-HIG Intravenous (IV)
n=7 Participants
Eligible participants will be randomized to receive an 8.5mL dose of COVID-HIG by IV infusion.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
|---|---|---|---|
|
Participants With AEs and SAEs After Study Treatment
Number of participants with any AE
|
6 Participants
|
3 Participants
|
4 Participants
|
|
Participants With AEs and SAEs After Study Treatment
Number of participants with any SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 0 to Day 57Population: Safety population includes all participants who received any amount of study treatment.
Number of adverse events (AEs) and serious adverse events (SAEs) in all participants reporting AEs/SAEs up to 56 days post-dosing.
Outcome measures
| Measure |
COVID-HIG Intramuscular (IM)
n=7 Participants
Eligible participants will be randomized to receive an 8.5mL dose of COVID-HIG by IM injections.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
COVID-HIG Subcutaneous (SC)
n=8 Participants
Eligible participants will be randomized to receive an 8.5mL dose of COVID-HIG by SC injections.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
COVID-HIG Intravenous (IV)
n=7 Participants
Eligible participants will be randomized to receive an 8.5mL dose of COVID-HIG by IV infusion.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
|---|---|---|---|
|
Total Number of AEs and SAEs After Study Treatment
Total number of SAEs for all participants reporting SAEs
|
0 Events
|
0 Events
|
0 Events
|
|
Total Number of AEs and SAEs After Study Treatment
Total number of adverse events (AEs) for all participants reporting AEs
|
9 Events
|
5 Events
|
9 Events
|
PRIMARY outcome
Timeframe: Day 1 to Day 57Population: The PK population included all subjects who received COVID-HIG and had an adequate set of evaluable PK samples (a suitable predose sample and at least one measurable postdose sample, with samples occurring after a positive SARS-CoV-2 test result excluded).
The area under the concentration-time curve from time 0 to the last quantifiable concentration of SARS-CoV-2 binding IgG antibodies after COVID-HIG dose. Data for PK calculations was collected: pre-dose, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 3, Day 4, Day 6, Day 8, Day 15, Day 29, Day 43, and Day 57.
Outcome measures
| Measure |
COVID-HIG Intramuscular (IM)
n=7 Participants
Eligible participants will be randomized to receive an 8.5mL dose of COVID-HIG by IM injections.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
COVID-HIG Subcutaneous (SC)
n=8 Participants
Eligible participants will be randomized to receive an 8.5mL dose of COVID-HIG by SC injections.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
COVID-HIG Intravenous (IV)
n=7 Participants
Eligible participants will be randomized to receive an 8.5mL dose of COVID-HIG by IV infusion.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
|---|---|---|---|
|
Pharmacokinetics Parameter of Area Under the Concentration-time Curve (AUC) From Time 0 to the Last Quantifiable Concentration (AUC0-last) of SARS-CoV-2 Antibodies After Dose of COVID-HIG
|
6435.44 h*Alliance Units (AU)/mL
Interval 1889.47 to 21918.78
|
9560.60 h*Alliance Units (AU)/mL
Interval 3382.99 to 27018.99
|
11883.46 h*Alliance Units (AU)/mL
Interval 6891.36 to 20491.83
|
PRIMARY outcome
Timeframe: Day 1 to Day 57Population: The PK population included all subjects who received COVID-HIG and had an adequate set of evaluable PK samples (a suitable predose sample and at least one measurable postdose sample, with samples occurring after a positive SARS-CoV-2 test result excluded).
Area under the concentration-time curve from time 0 to the last quantifiable concentration plus the additional area extrapolated to infinity of SARS-CoV-2 binding IgG antibodies after COVID-HIG dose. Data for PK calculations was collected: pre-dose, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 3, Day 4, Day 6, Day 8, Day 15, Day 29, Day 43, and Day 57.
Outcome measures
| Measure |
COVID-HIG Intramuscular (IM)
n=2 Participants
Eligible participants will be randomized to receive an 8.5mL dose of COVID-HIG by IM injections.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
COVID-HIG Subcutaneous (SC)
n=3 Participants
Eligible participants will be randomized to receive an 8.5mL dose of COVID-HIG by SC injections.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
COVID-HIG Intravenous (IV)
n=4 Participants
Eligible participants will be randomized to receive an 8.5mL dose of COVID-HIG by IV infusion.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
|---|---|---|---|
|
Pharmacokinetics Parameter of Area Under the Concentration-time (AUC) From Time 0 to Infinity (AUC0-inf) After Dose of COVID-HIGIV
|
8042.38 h*AU/mL
Interval 2561.73 to 25248.55
|
6875.52 h*AU/mL
Interval 5521.48 to 8561.6
|
19212.18 h*AU/mL
Interval 7569.07 to 48765.28
|
PRIMARY outcome
Timeframe: Day 1 to Day 57Population: The PK population included all subjects who received COVID-HIG and had an adequate set of evaluable PK samples (a suitable predose sample and at least one measurable postdose sample, with samples occurring after a positive SARS-CoV-2 test result excluded).
The Cmax of SARS-CoV-2 binding IgG antibodies observed after COVID-HIG dose. Data for PK calculations was collected: pre-dose, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 3, Day 4, Day 6, Day 8, Day 15, Day 29, Day 43, and Day 57.
Outcome measures
| Measure |
COVID-HIG Intramuscular (IM)
n=7 Participants
Eligible participants will be randomized to receive an 8.5mL dose of COVID-HIG by IM injections.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
COVID-HIG Subcutaneous (SC)
n=8 Participants
Eligible participants will be randomized to receive an 8.5mL dose of COVID-HIG by SC injections.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
COVID-HIG Intravenous (IV)
n=7 Participants
Eligible participants will be randomized to receive an 8.5mL dose of COVID-HIG by IV infusion.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
|---|---|---|---|
|
Pharmacokinetics Parameter of Maximum Observed Concentration (Cmax) of SARS-CoV-2 Antibodies Observed After Dose of COVID-HIG
|
17.02 AU/mL
Interval 8.0 to 36.24
|
16.24 AU/mL
Interval 7.62 to 34.65
|
56.88 AU/mL
Interval 30.41 to 106.39
|
PRIMARY outcome
Timeframe: Day 1 to Day 57Population: The PK population included all subjects who received COVID-HIG and had an adequate set of evaluable PK samples (a suitable predose sample and at least one measurable postdose sample, with samples occurring after a positive SARS-CoV-2 test result excluded).
Time at which Cmax occurs (Tmax) after COVID-HIG dose. Data for PK calculations was collected: pre-dose, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 3, Day 4, Day 6, Day 8, Day 15, Day 29, Day 43, and Day 57.
Outcome measures
| Measure |
COVID-HIG Intramuscular (IM)
n=7 Participants
Eligible participants will be randomized to receive an 8.5mL dose of COVID-HIG by IM injections.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
COVID-HIG Subcutaneous (SC)
n=8 Participants
Eligible participants will be randomized to receive an 8.5mL dose of COVID-HIG by SC injections.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
COVID-HIG Intravenous (IV)
n=7 Participants
Eligible participants will be randomized to receive an 8.5mL dose of COVID-HIG by IV infusion.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
|---|---|---|---|
|
Pharmacokinetics Parameter of Time at Which Cmax Occurs After Dose of COVID-HIG
|
174.71 hours
Standard Deviation 221.13
|
201.01 hours
Standard Deviation 213.76
|
1.53 hours
Standard Deviation 0.53
|
PRIMARY outcome
Timeframe: Day 1 to Day 29Population: The PK population included all subjects who received COVID-HIG and had an adequate set of evaluable PK samples up to Day 29.
The observed trough concentration of SARS-CoV-2 binding IgG antibodies 28 days after COVID-HIG dose. Data for PK calculations was collected: pre-dose, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 3, Day 4, Day 6, Day 8, Day 15, and Day 29.
Outcome measures
| Measure |
COVID-HIG Intramuscular (IM)
n=4 Participants
Eligible participants will be randomized to receive an 8.5mL dose of COVID-HIG by IM injections.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
COVID-HIG Subcutaneous (SC)
n=6 Participants
Eligible participants will be randomized to receive an 8.5mL dose of COVID-HIG by SC injections.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
COVID-HIG Intravenous (IV)
n=5 Participants
Eligible participants will be randomized to receive an 8.5mL dose of COVID-HIG by IV infusion.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
|---|---|---|---|
|
Pharmacokinetics Parameter of Trough Concentration of SARS-CoV-2 Antibodies Observed 28 Days After Dose (Cmin28d) of COVID-HIG
|
3.67 AU/mL
Interval 0.0 to 15928.95
|
7.55 AU/mL
Interval 2.36 to 24.19
|
8.15 AU/mL
Interval 5.58 to 11.91
|
SECONDARY outcome
Timeframe: Day 1 to Day 29Population: The PK population included all subjects who received COVID-HIG and had an adequate set of evaluable PK samples up to Day 29.
AUC from time 0 to 28 days of SARS-CoV-2 binding IgG antibodies after COVID-HIG dose. Data for PK calculations was collected: pre-dose, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 3, Day 4, Day 6, Day 8, Day 15, and Day 29.
Outcome measures
| Measure |
COVID-HIG Intramuscular (IM)
n=4 Participants
Eligible participants will be randomized to receive an 8.5mL dose of COVID-HIG by IM injections.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
COVID-HIG Subcutaneous (SC)
n=6 Participants
Eligible participants will be randomized to receive an 8.5mL dose of COVID-HIG by SC injections.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
COVID-HIG Intravenous (IV)
n=5 Participants
Eligible participants will be randomized to receive an 8.5mL dose of COVID-HIG by IV infusion.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
|---|---|---|---|
|
Pharmacokinetics Parameter of Area Under the Concentration-time Curve (AUC) From Time 0 to 28 Days (AUC0-28d) After Dose of COVID-HIG.
|
14610.82 h*AU/mL
Interval 3072.14 to 69487.73
|
14624.92 h*AU/mL
Interval 4470.66 to 47842.64
|
12182.14 h*AU/mL
Interval 6935.59 to 21397.55
|
SECONDARY outcome
Timeframe: Day 1 to Day 15Population: The PK population included all subjects who received COVID-HIGIV and had an adequate set of evaluable PK samples up until Day 15.
AUC from time 0 to 14 days (AUC0-14d) of SARS-CoV-2 binding IgG antibodies after COVID-HIG. Data for PK calculations was collected: pre-dose, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 3, Day 4, Day 6, Day 8, and Day 15.
Outcome measures
| Measure |
COVID-HIG Intramuscular (IM)
n=5 Participants
Eligible participants will be randomized to receive an 8.5mL dose of COVID-HIG by IM injections.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
COVID-HIG Subcutaneous (SC)
n=7 Participants
Eligible participants will be randomized to receive an 8.5mL dose of COVID-HIG by SC injections.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
COVID-HIG Intravenous (IV)
n=7 Participants
Eligible participants will be randomized to receive an 8.5mL dose of COVID-HIG by IV infusion.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
|---|---|---|---|
|
Pharmacokinetics Parameter of Area Under the Concentration-time Curve (AUC) From Time 0 to 14 Days After Dose of COVID-HIG
|
12057.04 h*AU/mL
Interval 3700.79 to 39281.36
|
11118.31 h*AU/mL
Interval 3465.31 to 35672.65
|
11883.46 h*AU/mL
Interval 6891.36 to 20491.83
|
SECONDARY outcome
Timeframe: Day 1 to Day 57Population: The PK population included all subjects who received COVID-HIG and had an adequate set of evaluable PK samples.
The apparent terminal elimination half-life (T1/2) after dose of COVID-HIG. Data for PK calculations was collected: pre-dose, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 3, Day 4, Day 6, Day 8, Day 15, Day 29, Day 43, and Day 57.
Outcome measures
| Measure |
COVID-HIG Intramuscular (IM)
n=2 Participants
Eligible participants will be randomized to receive an 8.5mL dose of COVID-HIG by IM injections.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
COVID-HIG Subcutaneous (SC)
n=3 Participants
Eligible participants will be randomized to receive an 8.5mL dose of COVID-HIG by SC injections.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
COVID-HIG Intravenous (IV)
n=4 Participants
Eligible participants will be randomized to receive an 8.5mL dose of COVID-HIG by IV infusion.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
|---|---|---|---|
|
Pharmacokinetics Parameter of Apparent Terminal Elimination Half-life (T1/2) After Dose of COVID-HIG
|
505.50 hours
Standard Deviation 128.13
|
535.70 hours
Standard Deviation 61.09
|
673.90 hours
Standard Deviation 356.02
|
SECONDARY outcome
Timeframe: Day 1 to Day 57Population: The PK population included all subjects who received COVID-HIG and had an adequate set of evaluable PK samples.
The systemic clearance (CL) of SARS-CoV-2 binding IgG antibodies after dose of COVID-HIG. . Data for PK calculations was collected: pre-dose, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 3, Day 4, Day 6, Day 8, Day 15, Day 29, Day 43, and Day 57.
Outcome measures
| Measure |
COVID-HIG Intramuscular (IM)
n=2 Participants
Eligible participants will be randomized to receive an 8.5mL dose of COVID-HIG by IM injections.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
COVID-HIG Subcutaneous (SC)
n=3 Participants
Eligible participants will be randomized to receive an 8.5mL dose of COVID-HIG by SC injections.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
COVID-HIG Intravenous (IV)
n=4 Participants
Eligible participants will be randomized to receive an 8.5mL dose of COVID-HIG by IV infusion.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
|---|---|---|---|
|
Pharmacokinetics Parameter of Systemic Clearance (CL) After Dose of COVID-HIG
|
0.0010 mL/h
Standard Deviation 0.0000
|
0.0010 mL/h
Standard Deviation 0.0000
|
0.0010 mL/h
Standard Deviation 0.0006
|
SECONDARY outcome
Timeframe: Day 1 to Day 57Population: The PK population included all subjects who received COVID-HIG and had an adequate set of evaluable PK samples.
The volume of distribution (Vz) of SARS-CoV-2 binding IgG antibodies after dose of COVID-HIG. Data for PK calculations was collected: pre-dose, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 3, Day 4, Day 6, Day 8, Day 15, Day 29, Day 43, and Day 57.
Outcome measures
| Measure |
COVID-HIG Intramuscular (IM)
n=2 Participants
Eligible participants will be randomized to receive an 8.5mL dose of COVID-HIG by IM injections.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
COVID-HIG Subcutaneous (SC)
n=3 Participants
Eligible participants will be randomized to receive an 8.5mL dose of COVID-HIG by SC injections.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
COVID-HIG Intravenous (IV)
n=4 Participants
Eligible participants will be randomized to receive an 8.5mL dose of COVID-HIG by IV infusion.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
|---|---|---|---|
|
Pharmacokinetic Parameter of Volume of Distribution (Vz) After Dose of COVID-HIG
|
0.75 mL
Interval 0.32 to 1.75
|
0.93 mL
Interval 0.67 to 1.28
|
0.35 mL
Interval 0.27 to 0.45
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 to Day 57Population: The PK population included all subjects who received COVID-HIG and had an adequate set of evaluable PK samples. In each arm, there were n=7 in the COVID-HIG IM arm, n=8 in the COVID-HIG SC arm and n=7 in the COVID-HIG IV arm. The overall participants analyzed per group as indicated in this bioavailability comparison is the sum of each of the respective groups indicated in the title/description.
AUC0-last ratios (bioavailability) compared between routes for comparable dose levels (COVID-HIG IM to SC; SC to IV; and IM to IV). Least square mean estimates and 90% confidence intervals were derived from ANOVA model with AUC0-last as dependent variable and administration route as fixed effect. Comparative bioavailability was defined as within \[80%, 125%\].
Outcome measures
| Measure |
COVID-HIG Intramuscular (IM)
n=15 Participants
Eligible participants will be randomized to receive an 8.5mL dose of COVID-HIG by IM injections.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
COVID-HIG Subcutaneous (SC)
n=14 Participants
Eligible participants will be randomized to receive an 8.5mL dose of COVID-HIG by SC injections.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
COVID-HIG Intravenous (IV)
n=15 Participants
Eligible participants will be randomized to receive an 8.5mL dose of COVID-HIG by IV infusion.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
|---|---|---|---|
|
Comparative Bioavailability: Area Under the Concentration-time Curve (AUC) From Time 0 to Last (AUC0-last) Ratios Between Administration Routes
|
0.67 ratio
Interval 0.25 to 1.82
|
0.54 ratio
Interval 0.19 to 1.51
|
0.80 ratio
Interval 0.3 to 2.17
|
Adverse Events
COVID-HIG Intramuscular (IM)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
COVID-HIG Subcutaneous (SC)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
COVID-HIG Intravenous (IV)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
COVID-HIG Intramuscular (IM)
n=7 participants at risk
Eligible subjects will be randomized to receive an 8.5mL dose of COVID-HIG by IM injections.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
COVID-HIG Subcutaneous (SC)
n=8 participants at risk
Eligible subjects will be randomized to receive an 8.5mL dose of COVID-HIG by SC injections.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
COVID-HIG Intravenous (IV)
n=7 participants at risk
Eligible subjects will be randomized to receive an 8.5mL dose of COVID-HIG by IV infusion.
COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.
COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation
|
|---|---|---|---|
|
Eye disorders
Visual Impairment
|
0.00%
0/7 • Adverse events were collected from Day 1 (Dosing Day) through Day 57 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 57 or early withdrawal.
Adverse events were unsolicited.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 57 or early withdrawal.
Adverse events were unsolicited.
|
|
Gastrointestinal disorders
Food Poisoning
|
0.00%
0/7 • Adverse events were collected from Day 1 (Dosing Day) through Day 57 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 57 or early withdrawal.
Adverse events were unsolicited.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 57 or early withdrawal.
Adverse events were unsolicited.
|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 57 or early withdrawal.
Adverse events were unsolicited.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 57 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/7 • Adverse events were collected from Day 1 (Dosing Day) through Day 57 or early withdrawal.
Adverse events were unsolicited.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7 • Adverse events were collected from Day 1 (Dosing Day) through Day 57 or early withdrawal.
Adverse events were unsolicited.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 57 or early withdrawal.
Adverse events were unsolicited.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 57 or early withdrawal.
Adverse events were unsolicited.
|
|
Infections and infestations
Asymptomatic COVID-19
|
42.9%
3/7 • Number of events 3 • Adverse events were collected from Day 1 (Dosing Day) through Day 57 or early withdrawal.
Adverse events were unsolicited.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 57 or early withdrawal.
Adverse events were unsolicited.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 57 or early withdrawal.
Adverse events were unsolicited.
|
|
Infections and infestations
Bacterial Vulvovaginitis
|
0.00%
0/7 • Adverse events were collected from Day 1 (Dosing Day) through Day 57 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 57 or early withdrawal.
Adverse events were unsolicited.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 57 or early withdrawal.
Adverse events were unsolicited.
|
|
Infections and infestations
COVID-19
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 57 or early withdrawal.
Adverse events were unsolicited.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 57 or early withdrawal.
Adverse events were unsolicited.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 57 or early withdrawal.
Adverse events were unsolicited.
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 57 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 57 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/7 • Adverse events were collected from Day 1 (Dosing Day) through Day 57 or early withdrawal.
Adverse events were unsolicited.
|
|
Nervous system disorders
Headache
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 57 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 57 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/7 • Adverse events were collected from Day 1 (Dosing Day) through Day 57 or early withdrawal.
Adverse events were unsolicited.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/7 • Adverse events were collected from Day 1 (Dosing Day) through Day 57 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 57 or early withdrawal.
Adverse events were unsolicited.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 57 or early withdrawal.
Adverse events were unsolicited.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/7 • Adverse events were collected from Day 1 (Dosing Day) through Day 57 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 57 or early withdrawal.
Adverse events were unsolicited.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 57 or early withdrawal.
Adverse events were unsolicited.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 57 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 57 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/7 • Adverse events were collected from Day 1 (Dosing Day) through Day 57 or early withdrawal.
Adverse events were unsolicited.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 57 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 57 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/7 • Adverse events were collected from Day 1 (Dosing Day) through Day 57 or early withdrawal.
Adverse events were unsolicited.
|
|
Vascular disorders
Hot flush
|
0.00%
0/7 • Adverse events were collected from Day 1 (Dosing Day) through Day 57 or early withdrawal.
Adverse events were unsolicited.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 57 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/7 • Adverse events were collected from Day 1 (Dosing Day) through Day 57 or early withdrawal.
Adverse events were unsolicited.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/7 • Adverse events were collected from Day 1 (Dosing Day) through Day 57 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 57 or early withdrawal.
Adverse events were unsolicited.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 57 or early withdrawal.
Adverse events were unsolicited.
|
Additional Information
Mila Mirceta, PhD, Senior Scientist, Clinical Research
Emergent BioSolutions Canada Inc
Phone: 204-275-4074
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place